Ultrasound and Photoacoustic Imaging for Cervical Cancer

NCT ID: NCT03318107

Last Updated: 2020-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2019-08-09

Brief Summary

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The investigators have developed co-registered transvaginal photoacoustic and ultrasound (US) imaging techniques that allow them to visualize ovarian tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development or residual tumors after systemic treatment that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes using a non-invasive imaging modality will greatly enhance the care for patients. The investigators plan to explore these techniques in monitoring cervical cancer treatment response and conduct pilot feasibility studies.

Detailed Description

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Conditions

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Cervical Cancer Cancer of the Cervix

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Transvaginal probe (Photoacoustic + ultrasound imaging)

* A transvaginal imaging probe using ultrasound and photoacoustic imaging will be inserted into the vagina and will use different frequencies of lights to create images
* This will occur before the first standard of care treatment, mid-treatment, end of treatment, and approximately 3 months after the end of treatment for a total of 4 imaging time points

Group Type EXPERIMENTAL

Transvaginal probe using photoacoustic and ultrasound imaging

Intervention Type DEVICE

-Four optical wavelengths of 730nm, 780nm, 800 nm, and 830 nm will be used to acquire data

Interventions

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Transvaginal probe using photoacoustic and ultrasound imaging

-Four optical wavelengths of 730nm, 780nm, 800 nm, and 830 nm will be used to acquire data

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of cervical cancer of any stage that will be treated with radiation therapy and concurrent chemotherapy.
* At least 18 years of age.
* Not pregnant and/or breastfeeding.
* Able to understand and willing to sign an IRB-approved written informed consent document.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Perry W Grigsby, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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201710024

Identifier Type: -

Identifier Source: org_study_id

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